Eptifibatide injection 20mg/10mL recall: Impurity Out of Spec
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC…
Why was Eptifibatide injection 20mg/10mL recalled?
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3EF22003, Exp 6/30/2025
- Product
- Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC…
- Recalling firm
- Eugia US LLC
- Quantity
- 15,500 single dose vials
- Distribution
- USA nationwide.
- Recall date
- June 26, 2024
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)